[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566603":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":116,"collaborators":26,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":26,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":26,"enrollmentInfo":127,"targetDuration":26,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Biosensors Europe SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BioFreedom™ Ultra DCS","EXPERIMENTAL","Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ Ultra stent if randomized to this arm (1:1 ratio)",[13],"Device: BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent",{"label":15,"type":16,"description":17,"interventionNames":18},"BioFreedom™ DCS","ACTIVE_COMPARATOR","Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ stent if randomized to this arm (1:1 ratio)",[19],"Device: BioFreedom™ stainless steel Biolimus A9™-coated stent",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent","Stent implantation",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"BioFreedom™ stainless steel Biolimus A9™-coated stent",[15],[31],{"name":32,"affiliation":33,"role":34},"Kamaraj a\u002Fl Selvaraj, Dr.","Hospital Serdang","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Kar Imm Ang, MSc.","CONTACT","+65 6213 0142","ki.ang@biosensors.com",[42,59,72,85,98,105],{"facility":43,"status":44,"city":45,"state":46,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hospital Sultanah Aminah","RECRUITING","Johor Bahru","Johor","Malaysia","MY",{"type":50,"coordinates":51},"Point",[52,53],103.7578,1.4655,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":26,"phoneExt":26,"email":58},"Gurudevan a\u002Fl Mahadevan, Dr.","mguru3579@yahoo.com",{"facility":60,"status":44,"city":61,"state":62,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Hospital Tengku Ampuan Afzan","Kuantan","Pahang",{"type":50,"coordinates":64},[65,66],103.326,3.8077,{"lat":66,"lon":65},[69],{"name":70,"role":38,"phone":26,"phoneExt":26,"email":71},"Anwar Irawan Bin Ruhani, Dr.","anwarruhani@gmail.com",{"facility":73,"status":44,"city":74,"state":75,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Hospital Raja Permaisuri Bainun","Ipoh","Perak",{"type":50,"coordinates":77},[78,79],101.0829,4.5841,{"lat":79,"lon":78},[82],{"name":83,"role":38,"phone":26,"phoneExt":26,"email":84},"Nor Hanim Bt. Mohd Amin, Dr.","norhanim.mohdamin@yahoo.com",{"facility":86,"status":44,"city":87,"state":88,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hospital Queen Elizabeth II","Kota Kinabalu","Sabah",{"type":50,"coordinates":90},[91,92],116.0724,5.9749,{"lat":92,"lon":91},[95],{"name":96,"role":38,"phone":26,"phoneExt":26,"email":97},"Liew Houng Bang, Dr.","hbliew22@gmail.com",{"facility":99,"status":44,"city":87,"state":100,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":26,"geoPoint":26,"contacts":101},"Pusat Jantung Hospital Umum Sarawak","Sarawak",[102],{"name":103,"role":38,"phone":26,"phoneExt":26,"email":104},"Ong Tiong Kiam, Dr.","ongtk@outlook.com",{"facility":33,"status":44,"city":106,"state":107,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Kajang","Selangor",{"type":50,"coordinates":109},[110,111],101.78875,2.99424,{"lat":111,"lon":110},[114],{"name":32,"role":38,"phone":26,"phoneExt":26,"email":115},"kamarajdoc@gmail.com",{"type":117,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100566603","leaders-free-iv-rct-biofreedom-ultra-vs-biofreedom-in-hbr-patients-100566603",false,"NCT06657326","LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients","Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Ultra Drug Coated Stent in Patients With High Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention","Inclusion Criteria:\n\n1. Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate at least one month of DAPT. This includes patients with stable angina, silent ischemia, acute coronary syndromes (ACS) (STEMI and NSTEMI), de novo lesions in native arteries with diameter stenosis \\>70% by visual estimation and evidence of ischemia in the territory of the target vessel(s).\n2. Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.\n\nExclusion Criteria:\n\n1. Pregnant and breastfeeding women\n2. Age \\\u003C18 years old\n3. Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent\n4. Patients expected not to comply with 1 month DAPT\n5. Active bleeding at the time of inclusion\n6. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only)\n7. Number of target lesions \\>2\n8. Patient requires a stent of diameter \\\u003C2.25mm\n9. Patient requires a stent of diameter \\>4.0mm\n10. Isolated ostial lesions within 3 mm of the origin of LAD or LCx (left main lesions involving the ostia of the LAD and\u002For LCx are eligible)\n11. Patient has known left ventricular ejection fraction (LVEF) \\\u003C30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary)\n12. Patient with chronic total occlusion(s) as target lesion(s)\n13. Severe calcification that might prevent sufficient expansion of the DES, unless pre-treated with a plaque modification device such as cutting balloon, scoring balloon or intravascular lithotripsy.\n\n    Note: Use of rotational or orbital atherectomy is also permitted.\n14. Cardiogenic shock\n15. Compliance with long-term single anti-platelet therapy unlikely\n16. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated\n17. Any PCI during the previous 12 months\n18. Participation in another clinical study (12 months after index procedure)\n19. Patients with a life expectancy of \\\u003C12 months","ALL","18 Years",{"count":128,"type":129},444,"ESTIMATED","INTERVENTIONAL",[132],"NA","This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.",[135,136,137,138,139],"Coronary Artery Disease","Chronic Stable Angina","Unstable Angina","Silent Ischemia","Acute Coronary Syndrome","2025-06-03",{"date":142,"type":143},"2025-06-05","ACTUAL",{"date":145,"type":143},"2024-12-18",{"date":147,"type":129},"2030-12",{"name":5,"class":6},6]